Role Overview:
The CSV Engineer will be responsible for ensuring that computerized systems used within
the organization comply with regulatory requirements and internal quality standards.
This role involves developing, writing, and executing Computer System Validation (CSV)
protocols, managing documentation, and supporting audits to maintain compliance with
GxP and other applicable regulations.
Key Responsibilities:
• Develop and author CSV protocols, including Installation Qualification (IQ),
Operational Qualification (OQ) on Kneat.
• Execute validation protocols and document results in accordance with company
SOPs and regulatory guidelines via Kneat.
• Perform risk assessments and impact analyses for computerized systems.
• Ensure compliance with FDA, EMA, and GAMP 5 guidelines for system
validation.
• Collaborate with Automation teams, Quality, and business stakeholders to
ensure systems meet user requirements and compliance standards.
• Maintain validation documentation and ensure traceability throughout the
system lifecycle.
• Support internal and external audits by providing validation evidence and
responding to queries.
• Troubleshoot validation issues and propose corrective actions.
• Participate in change control processes for validated systems.
Key Requirements:
• Education: Bachelor's degree in Computer Science, Engineering, Life Sciences,
or related field.
Experience:
• Minimum 2+ years in Computer System Validation within a regulated
environment (pharmaceutical, biotech, or medical devices preferred).
• Hands -on experience writing and executing validation protocols (IQ/OQ/) on
Kneat.
Technical Skills:
• Strong understanding of GAMP 5, 21 CFR Part 11, and Annex 11 compliance
requirements.
• Familiarity with DeltaV, PLC, MES, or other GxP systems.
Soft Skills:
• Excellent documentation and communication skills.
• Strong attention to detail and ability to work under strict timelines